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Biomarker Envy IV: The Exmobaby

June 12, 2011

To what lengths would you go to keep your child healthy?  Organic, non-GMO baby food?  Hypoallergenic baby lotions and shampoos?  Bisphenol-free baby bottles?  How about a battery-powered biosensor garment that transmits ECG, skin temperature, and other biometric data about your baby wirelessly to your computer or via SMS message to your smartphone in real time?

Never fear, the Exmobaby is here.  Introduced late last year (and shown in the picture above—by the way, I don’t think that’s Jeff Daniels as a paid spokesman), the Exmobaby is a sleep garment designed for babies aged 0-12 months, which contains “embedded, non-contact sensors, a battery-powered Zigbee transmitter pod, a USB Zigbee receiver dongle that plugs into a Windows PC,” and all the necessary software.  Their slogan is “We Know How Your Baby Feels.”

It sounds like science fiction, but in reality it’s just a souped-up, high-tech version of a baby monitor.  But is it an improvement upon the audio- or video baby monitors currently available?  Exmovere certainly thinks so.  And, luckily for them, there’s no shortage of worried parents who are willing to pay for peace of mind (the device starts at $1000 and goes up to $2500, plus monthly data charges). [Note: please see addendum below.]

But while this might be an example of “a fool and his money being soon parted,” Exmovere makes some claims about the product that are highly questionable.  I first learned about the Exmobaby in a post on the KevinMD website, in which Exmovere’s CEO, David Bychkov, commented that “using Exmobaby to observe and record physiological data symptomatic of emotional changes can be useful… if you are a parent of a child with autism.”

In other words, this isn’t just a fancy monitoring device, this is a high-tech way of understanding your child’s thoughts and emotions—an “emotional umbilical cord between mother and child”—and, quite possibly, a way to diagnose a psychiatric, neurodevelopmental disorder in your newborn, all in the comfort of your own home.

I surfed over to the Exmobaby web site, whose home page shows a smiling, happy infant wearing these newfangled jammies.  Cute!  And the device (?) looks harmless enough.  But the FAQ page is where it gets interesting (or scary, depending on your position).  One question asks, “how is it possible to detect emotional states using Exmobaby?”  The response sounds like pure 21st century biobehavioral mumbo jumbo:

Detection of emotion involves software that compares heart rate, delta temperature and movement data (arousal) to heart rate variability and skin temperature (valence). These data, if tracked over time, enable a system to “guess” from a series of words that could be used to describe an emotional state: anger, fatigue, depression, joy, etc….In the case of babies, Exmovere is asking its users to try something new: name states. Exmobaby software will monitor trends in vital states. Parents will be asked to name states, such as “giggly” or “grumpy,” and the system can and will alert them when the underlying readings that match those states are detected. The idea is … to create a deeper level of communication between babies and their parents at the beginning of such a critical relationship.

In plain English: they’re asking parents to correlate data from the Exmobaby software (rather than their direct observations of the baby, which is how parents used to interact with their kids) with what they consider to be the baby’s emotional state.  Thus:  “My baby’s happy because the software says he is” rather than using old-fashioned signs—you know, like smiles and giggles.

The Exmovere website also includes an article, clearly written for parents, on “Exmobaby and Autism.”  Now, autism and “autism-spectrum disorders” (ASDs) are hot topics receiving a great deal of attention these days.  ASDs currently have an estimated prevalence of 1 in 110 (and rising rapidly), with an average age of diagnosis of approximately 4 years.  Nonetheless, parents of children with ASDs begin to identify concerns by the age of 12 to 18 months, and finding a “biomarker” to enable earlier diagnosis would allay the fears and insecurities of new parents.

But is Exmovere preying on precisely these fears and insecurities?  Well, let’s first ask: is it even reasonable to think about diagnosing ASDs before the age of 12 months (when the Exmobaby garment would be worn?).  A recent study showed that ASDs could be diagnosed as early as 14 months of age, based on social and communication development (but no biometric measures).  The American Association of Pediatrics recommends ASD screening (an interview with the parents and structured observation of the child) at ages 18 and 24 months, no earlier.  And a recent article in Pediatrics remarked that there are few measures sensitive and specific enough to detect ASD before 2 years of age (and, again, no “biological” measures to speak of).

The Exmobaby handout (which I’ve uploaded here), on the other hand, is a perfect example of a drug/device manufacturer capitalizing on the fears of parents by conflating statistics, commentary, and recommendations in a way that makes their device sound like a vital necessity for healthy infant development.  It’s deceptive marketing, pure and simple.

For example, it states “One of the ‘red flags’ in early diagnosis of ASDs is a lack of response from baby to the use of their name. Parents can potentially use Exmobaby to record times when baby’s name was said so that the reports will correlate any movement or vital sign response.”  Also, “specific tests can be designed in consultation with pediatricians to use Exmobaby to assist with diagnoses of ASDs and related developmental disorders.”  Never mind that there’s nothing in the literature correlating movement or vital-sign responses with diagnosing ASDs in this age group.

Conveniently, Exmovere also included its marketing strategy on its website (available here). It’s clear they’re planning to market Exmobaby as a garment (“a $5 billion per year worldwide market”) and not as a medical device.  That’s probably a good idea.  Or is it?  Bypassing medical professionals and tapping into a wide market of “worried well” might be good for business, but what about the “downstream” impact on our health care system?

So many questions.  But I’ll have to address them some other time, because I need to go make a sandwich.  I just got a text message telling me I’m hungry.

Addendum:  After posting this article, I received an email from Exmovere’s Investor Relations Advisor who pointed out that the $1000-$2500 prices I quoted above are for Evaluation Kits, specifically for distributors, researchers, and hospitals.  Exmobaby is not available for retail purchase at this time.  They anticipate a lower cost when the device/garment is sold directly to end users.

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